22 Randomized trial of laparoscopic versus abdominal hysterectomy for benign indications and impact on surgical success

Abstract

To examine the differences in patient-centered goals in individuals undergoing laparoscopic versus abdominal hysterectomy for benign indications. This abstract is a sub-analysis of a prospective, randomized controlled trial examining the impact of laparoscopic versus abdominal hysterectomy on patient-centered outcomes including quality of life, pain, and productivity. At each pre-operative visit, each participant reported top three patient-centered goals they hoped to achieve prior to undergoing a hysterectomy. In addition, participants rated their subjective achievement of goals from 1 to 10, with 1 (goal not achieved) and 8 to 10 (goal achieved). The subjects were then randomized to total laparoscopic (TLH) or total abdominal hysterectomy (TAH). Following surgery, repeat assessment of goal achievement was obtained within each group on post-operative day 1, at 6 weeks, 6 months than 12 months post-operatively. In addition, the length of time to successful goal achievement (scores of 8 or higher during any post-operative period) was recorded in all participants. Power analysis was based on differences in the primary outcome of the initial study: Quality of Life as scored by the SF-36 form. With a clinically significant differences of 15 points in the SF-36 required a sample size of 29 patients in each group for a power of 80% with a two-sided significance level of 0.05. With that, differences in goal achievement rates and the length of time to goal achievement were examined between TLH and TAH groups using the calculated sample size of the initial study. A total of 91 participants undergoing benign hysterectomy were enrolled and randomized. Three patients were lost to follow-up, with 88 subjects available for final analysis. The top three goals listed respectively were: “Abnormal Uterine Bleeding,” (AUB) “Pelvic Pain,” (PP) and “Quality of Life.” (QOL). Overall, there were no significant differences in the percentage of goal achievement between TLH and TAH groups for QOL (69% vs 67%, P = 0.88), for AUB (67% vs 51%, P = 0.14), and PP (53% vs 49%, P = 0.67), though it appears that participants who listed QOL as their top goal were more likely to achieve the goal. The mode of hysterectomy did not appear to alter differences in goal achievement. In addition, there were no significant differences in the length of time to goal achievement between TLH and TAH groups for QOL (156 days vs 159 days, P = 0.99), for AUB (96 vs 116, P = 0.25), and PP (146 vs 143, P = 0.80). In conclusion, there were no significant differences in goal achievement rates between TLH versus TAH groups regardless of the desired patient-centered goals, though the majority of participants achieved their respective goals in both groups. In addition, there were no differences in length of time to goal achievement between the two groups. This study suggests that a hysterectomy itself may have a therapeutic effect on patient-centered outcomes irrespective of the route of surgery.